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CJEU Confirms SPC Term Can be Recalculated

Feb 1 2018 - 12:01

On December 20, 2017, the Court of Justice of the European Union (CJEU) issued a judgement in case C-492/16 (Incyte Corporation) stating that its decision in case C-471/14 (Seattle Genetics) from October 2015 had retroactive effect, meaning that holders of supplementary protection certificates (SPCs) granted before October 2015 may, according to Article 18 of SPC Regulation No. 469/2009, ask for the recalculation of their SPC duration, provided that the SPC has not expired.

In the Seattle Genetics case, the CJEU was asked how “the date of the first authorisation to place the product on the market” in Article 13(1) of the SPC Regulation should be interpreted, considering that a marketing authorization had two dates:

The date of the decision granting the marketing authorization; and

The date the applicant is notified of the marketing authorization approval.

The CJEU decided that the date to be used should be the notification date, meaning that the duration of SPC applications following the Seattle Genetics judgement should be calculated on the basis of the marketing authorization notification date.

After this case, some national intellectual property offices in the European Union allowed holders to request the recalculation of the duration of SPCs granted before October 2015. Other offices, however, refused to accept retroactive recalculation requests.

The Incyte Corporation case was brought before the CJEU following Hungarian IPO’s refusal to recalculate the duration of an SPC they had granted in 2014.